| CTRI Number |
CTRI/2022/06/043550 [Registered on: 28/06/2022] Trial Registered Prospectively |
| Last Modified On: |
17/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of patolakaturohinyadi churna and karaveeradi lepa in vicharchika |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of patolakaturohinyadi churna and karaveeradi lepa in the management of vicharchika w.s.r to eczema |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanju Ratnam TS |
| Designation |
PG Scholar |
| Affiliation |
Madan Mohan Malviya Government Ayurved college,Udaipur |
| Address |
PG Department of kayachikitsa
Madan Mohan Malviya Government Ayurved college
Ambamata scheme,Radaji circle,Udaipur,Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9400646620 |
| Fax |
|
| Email |
sanjuratnamts00099@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indumati Sharma |
| Designation |
Associate Professor |
| Affiliation |
Madan Mohan Malviya Government Ayurved college,Udaipur |
| Address |
PG Department of kayachikitsa
Madan Mohan Malviya Government Ayurved college
Ambamata scheme,Radaji circle,Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
7976972310 |
| Fax |
|
| Email |
drindusharma4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Indumati Sharma |
| Designation |
Associate Professor |
| Affiliation |
Madan Mohan Malviya Government Ayurved college,Udaipur |
| Address |
PG Department of kayachikitsa
Madan Mohan Malviya Government Ayurved college
Ambamata scheme,Radaji circle,Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
7976972310 |
| Fax |
|
| Email |
drindusharma4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malviya Government Ayurved college,Udaipur |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Government Ayurved college |
| Address |
Ambamata scheme,Radaji circle,Udaipur
PIN:313001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanju Ratnam TS |
Madan Mohan Malviya Government Ayurved college,Udaipur |
OPD No:2
PG Department of kayachikitsa
Madan Mohan Malviya Government Ayurved college and associated hospitals
Udaipur
RAJASTHAN |
9400646620
sanjuratnamts00099@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Madan Mohan Malviya Government Ayurved College,Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L208||Other atopic dermatitis. Ayurveda Condition: VICARCIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Patolakaturohinyadi churna, Reference: Astangahridaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Patolakaturohinyadi churna, Reference: Astangahridaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: -(2) Medicine Name: Karaveeradi lepa, Reference: Astangahridaya, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Gomutra), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients having signs and symptoms of vicharchika
2)Having complaints less than 3 years |
|
| ExclusionCriteria |
| Details |
1)Patients below 15 years and above 70 years
2)Having complaints more than 3 years
3)Evidence of skin malignancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Improvement in signs and symptoms of vicharchika
2)Improvement in ESR value |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Improvement in signs and symptoms of vicharchika
2)Improvement in ESR value |
15 days and 30 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is to evaluate the efficacy of patolakaturohinyadi churna and karaveeradi lepa in the management of vicharchika w.s.r to eczema.This is a multiple arm,parallel group,randomised trial conducted in 30 patients.In this study,groupA(15 patients)will be provided with patolakaturohinyadi churna and groupB(15patients)will be provided with patolakaturohinyadi churna and karaveeradi lepa.The study will be conducted for 45 days. |